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CTRI Number  CTRI/2025/08/093354 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 08/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Mechanistic trial of problem solving and behavioural activation for youth depression 
Scientific Title of Study   Mechanistic trial of problem solving and behavioural activation for youth depression (METROPOLIS) 
Trial Acronym  METROPOLIS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pattie Gonsalves 
Designation  Project Director (Indian PI) 
Affiliation  Sangath 
Address  Sangath, E-334, Ground Floor, East of Kailash, New Delhi

South
DELHI
110065
India 
Phone  9899419704  
Fax    
Email  pattie.gonsalves@sangath.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pattie Gonsalves 
Designation  Project Director (Indian PI) 
Affiliation  Sangath 
Address  Sangath, E-334, Ground Floor, East of Kailash, New Delhi

South
DELHI
110065
India 
Phone  9899419704  
Fax    
Email  pattie.gonsalves@sangath.in  
 
Details of Contact Person
Public Query  
Name  Dr Pattie Gonsalves 
Designation  Project Director (Indian PI) 
Affiliation  Sangath 
Address  Sangath, E-334, Ground Floor, East of Kailash, New Delhi

South
DELHI
110065
India 
Phone  9899419704  
Fax    
Email  pattie.gonsalves@sangath.in  
 
Source of Monetary or Material Support  
Research grant from Wellcome Trust (Grant number: 226786/A/22/Z) 
 
Primary Sponsor  
Name  King’s College London (KCL) 
Address  Strand, London WC2R2LS, United Kingdom 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanika Malik  O P Jindal Global University   Sonipat Narela Road, Near Jagdishpur Village
Sonipat
HARYANA 		 9910577218

kmalik1@jgu.edu.in 
Dr Pattie Gonsalves  Sangath  E-334 Ground Floor, East of Kailash
South
DELHI 		 9899419704

pattie.gonsalves@sangath.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kings College London (KCL)  Approved 
OP Jindal Global University Institutional Review Board (IRB)  Approved 
Sangath Institutional Review Board (IRB)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants scoring 10 and above on the Patient Health Questionnaire-9 item scale (PHQ-9) will be included in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioural Activation (BA)  Brief Behavioural Activation (BA) intervention delivered over 4–5 sessions (approximately weekly) with a trained peer supporter, primarily in person, with some flexibility for spacing of sessions and online or phone-based delivery. Participants will additionally receive a printed booklet tailored to their assigned intervention, and they continue to have access to usual care throughout the study. 
Intervention  Problem-Solving (PS)  Brief Problem-Solving (PS) intervention delivered over 4–5 sessions (approximately weekly) with a trained peer supporter (“Saathi”), primarily in person, with some flexibility for spacing of sessions and online or phone-based delivery. Participants will additionally receive a printed booklet tailored to their assigned intervention, and they continue to have access to usual care throughout the study. 
Comparator Agent  Study Skills (SS)  Brief Study Skills (SS) intervention is an active control (comparator) delivered over 4–5 sessions (approximately weekly) with a trained peer supporter, primarily in person, with some flexibility for spacing of sessions and online or phone-based delivery. Participants will additionally receive a printed booklet tailored to their assigned intervention, and they continue to have access to usual care throughout the study. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1) Aged 18 to 24 years.
2) Enrolled as a student (undergraduate or postgraduate) at specified campus locations in New Delhi.
3) Proficient in written and spoken English or Hindi, as needed to participate fully in study procedures.
4) Willing and able to provide informed consent to participate.
5)PHQ-9 total score of 10+. 
 
ExclusionCriteria 
Details  Exclusion criteria:
1) Outside of the target age range.
2) Not enrolled as a student at one of the specified campus locations.
3) Unable to speak or write in English or Hindi as needed to participate fully in study procedures.
4) Unwilling or unable to provide informed consent.
5) Suicidal ideation (identified on PHQ-9) AND plan/intent/past attempt (identified on Columbia-Suicide Severity Rating Scale (CSSRS)). 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Patient Health Questionnaire-9-item version (PHQ-9) (Kroenke, Spitzer & Williams, 2001)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Generalised Anxiety Disorder-7-item version (GAD-7) (Spitzer, Kroenke, Williams & Löwe, 2006)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
WHO Disability Assessment Schedule Version 2.0 (WHODAS 2.0) (Uston et al., 2010)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Academic Behavioural Confidence scale (ABC) (Sander & Sanders, 2003)   1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Problem-Solving Inventory (20-item version, PSI-20) (Pretorius, et al., 2023)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Behavioural Activation for Depression Scale, Short Form (BADS-SF) (Manos, Kanter & Luo, 2011)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Environmental Reward Observation Scale (EROS) (Armento & Hopko, 2007)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
University of California Undergraduate Experience Survey (UCEUS) (Brint & Cantwell, 2010)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Adult Hope Scale (AHS) (Snyder et al., 1991)  1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Working Alliance Inventory - Short Revised (WAI-SR) (Hatcher & Gillaspy, 2006)  1) 6 Weeks
 
Multiple Identity Minority Stress Scale (MIMSS) (Mathew et al., in preparation) (NB: to be tested as a moderator)   1) Baseline  
Brief Daily Stressors Screening Tool (BDSST) (Scholten et al., 2020) (NB: to be tested as a moderator)   1) Baseline  
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) (Herdman et al., 2011) (NB: to be used for economic evaluation)   1) Baseline
2) 6 Weeks
3) 6 Months
4) 12 Months 
Client Service Receipt Inventory (CSRI) – adapted (Nadkarni et al., 2024; PSSRU, 2025) (NB: to be used for economic evaluation)   1) Baseline
2) 12 Months 
Cost of Receiving Treatment Questionnaire (CRTQ) (NB: to be used for economic evaluation)   1) 6 Weeks  
Modified EDinburgh Adverse effects of Psychological Therapy (EDAPTS) (adapted from McGlanaghy et al., 2021) (NB: to be used for monitoring potential adverse effects)  1) 6 Weeks
2) 6 Months
3) 12 Months 
 
Target Sample Size   Total Sample Size="714"
Sample Size from India="714" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Deidentified participant data will be shared in line with the funder data sharing policy and institutional policies at the sponsor institution

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Deidentified data will be made available through Kings Open Research Data System

  6. For how long will this data be available start date provided 01-04-2028 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a three-arm, individually randomised controlled trial (RCT) with mediation analysis, comparing a peer-delivered problem-solving intervention, peer-delivered behavioural activation intervention, and peer-delivered study skills training (attention control).

The primary outcome is participant-reported depression (Patient Health Questionnaire-9-item version; PHQ-9) at 12 months. An embedded process evaluation will use a realist approach to investigate the underlying generative mechanisms that explain ‘how’ the outcomes were caused and the influence of context. An economic evaluation will use cost-consequences analysis to compare the costs and outcomes associated with all three interventions separately. 

Full details of the study are provided in our approved HMSC application (BioRRAP ID: SAN22022024).

 
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